Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals

Introduction

Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and configuration.

Key Challenges

  • It was required to configure ClinSpark as it was a turnkey, enterprise-level system.
  • Existing Axis Clinicals workflows and documentation needed to be modified to accommodate ClinSpark’s enhanced capabilities.
  • Validation of technology, workflow process, governance and control was required.

What was achieved for the client:

  • Reduction in Human errors by 85%
  • Reduction in Cost by 40%

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